A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection

• Status: Terminated
• Trial end date: 2018-02-13
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the durability of Sustained virologic response (SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS) with NCT Numbers NCT02569710 and NCT02765490.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Simeprevir

Criteria

Inclusion Criteria:

• Participant was randomized to a regimen containing Odalasvir (ODV) with AL-335 with or without Simeprevir in a preceding Phase 2 or Phase 3 study (parent study)

• Participant received at least 1 dose of ODV with AL-335 with or without SMV in the parent study

• Participant has completed the last post-therapy follow-up visit of the parent study ( LPVPS) and has not passed the screening period of 6 + 3 months after the LPVPS

• Participant has signed an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study

Exclusion Criteria:

• Participant is currently enrolled or plans to enroll in another study with an investigational drug (including investigational vaccines) or an invasive investigational medical device between the LPVPS and Visit 6 of the present study (36 months (+/-) 4 weeks after the LPVPS of the parent study)

• Participant received antiviral or immunomodulating treatment, including therapeutic vaccines, for HCV infection between the LPVPS and the screening visit of the present study, or is planned to receive such treatment during the period of this follow-up study

• Participant is not able to adhere to the requirements of the follow-up study